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New Delhi: The proposal to introduce a new category of over the counter (OTC) medicines which will empower the pharmacists to dispense drugs for minor conditions without a doctor’s prescription has been approved by the government’s advisory body on drugs, the Drug Consultative Committee (DCC).

A subcommittee has been constituted by DCC comprising of various health experts to examine the modalities and shortlist the drugs that can be brought under the category of OTC.

Medical Dialogues had earlier reported that a special provision to include OTC medicines in the Drugs and Cosmetics rules had been proposed by the Central Drugs Standard Control Organization (CDSCO).

An official aware of the development said told LiveMint that “the DCC chaired by the Drug Controller General of India gave its in-principle approval to the proposal. The subcommittee will work on the modalities and will present its report before the Drug Technical Advisory Board (DTAB), the chief advisory board—on drugs next month.” Once approved by the DTAB, the proposal will be sent to the ministry of health and family welfare for final notification.

“International practices show that there is a separate category of drugs which are harmless and safe enough to be dispensed without any prescription. We want to bring this concept in India too which will help people skip doctor’s visit for common ailments. This will make access to drugs easier for not only those living in urban areas but those living in rural areas and mostly dependent on quacks. The pharmacists are qualified to provide these services and have been underutilized,” he added.

Kailash Gupta, president, All India Chemists, and Distributors Federation said, “the expanded powers of pharmacists will increase convenience and accessibility for those who need refills or have a minor condition.”

A recent report in TOI states that the government is set to add around 100 new drugs to the list of over-the-counter (OTC) medicines which are currently sold on prescription to make them more accessible and to reduce the irrational application or misuse of high-risk drugs, especially antibiotics.

Drugs controller general of India (DCGI), G N Singh told TOI, “We are planning to introduce a separate schedule for OTC drugs. This will include commonly used drugs which are low risk and have been in use for a long term with proven efficacy. Besides, we are also considering such medicines available over the counter in other developed international markets.”

This leads to concerns about misuse of medicines and anti-microbial resistance. “ Apart from making commonly used drugs accessible, our main aim is to tackle the problem of antibiotic resistance. By making the rulebook simple, we want to ensure that everyone abides by it,“ Singh added.

The regulator may also consider placing some medicines for diabetes and hypertension which are considered low-risk and frequently prescribed under the OTC category at a later stage, an official said.

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